FDA Medical Device Recalls (openFDA)
Caridian BCT, Incorporated: Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.
- Recall number
- Z-0191-2012
- Recalling firm
- Caridian BCT, Incorporated
- Product
- Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.
- Status
- Terminated
- Initiated
- 2011-09-21
- Posted
- 2011-11-16
- Terminated
- 2013-02-01
- Reason
- Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
- Root cause
- Software design
- Action
- CaridianBCT sent a "Safety Alert" letter dated September 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm will be sending a recall letter to consignees in November 2011, stating they are voluntarily recalling the software and will provide an upgrade once the software has been approved. If you have any further questions please contact your CaridianBCT Representative, the CaridianBCT Support Center at 1-877-3-FYU-BCT ( US Toll free 1-877-299-4228 ) or (303) 231-HELP ) ( 1 (303) 231-4357, or your local CaridianBCT Customer Service office.
- Quantity
- 852 units (US: 333; Foreign: 519)
- Distribution
- Worldwide Distribution -- USA ( nationwide ) and the countries of Australia, Belgium, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Pakistan, Republic of Korea, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand and Vietnam.
- Lot, serial or model codes
- Serial Numbers: 1P00100 - 1P00XXX
- 510(k) numbers
- ["K071079","K103090"]
- PMA numbers
- not on file
- Product code
- LKN
- Firm FEI
- 1000117351
- Firm city
- Lakewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28